A Study of Valsartan Administered Once Daily Versus Twice Daily, in Patients With Stable, Chronic Heart Failure

Condition(s) targeted: Chronic Heart Failure

Intervention: valsartan 160 mg (Drug); valsartan 160 mg BID (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director

This study will evaluate the tolerability and safety of valsartan in patients with stable, chronic heart failure (NYHA Class ll-lll). The 12-week double blind study has a 2-week (maximum) screening, and a 10-week active treatment phase. In each of the treatment arms (QD and BID), patients are up-titrated to a maximum valsartan total daily dose of 320 mg. Patients remain on their prior CHF standard care therapy throughout the study period, and the up-titration of valsartan is based on patient tolerability.

Official title: A 12-Week Multicenter, 2-Arm Regimen, Exploratory Study to Evaluate the Tolerability and Safety of Valsartan Administered Once Daily vs Daily, in Patients With Stable, Chronic Heart Failure (NYHA Class ll-Lll)

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Tolerability as assessed by laboratory tests for potassium, creatinine, and on systolic blood pressure, symptoms of low blood pressure, and symptoms of heart failure

Secondary outcome:

Patients reaching target dose at 10 weeks

Change from baseline in systolic blood pressure at each study visit

Change from baseline in diastolic blood pressure at each study visit

Change from baseline in blood potassium at each study visit

Change from baseline in blood creatinine at each study visit

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria

- Males or females aged 18 years or older

- Diagnosis of chronic heart failure (CHF), in NYHA Class ll-lll beginning at least 3

months prior to Visit 1

- Patients must remain on their prior standard care CHF therapy

Exclusion Criteria

- Diagnosis of severe hypertension (SBP>180 and DBP>110 mm Hg)

- Right heart failure due to pulmonary disease

- Presence of rapidly deteriorating heart failure

- MI or cardiac surgery, including PTCA within 3 months of Visit 1

- Unstable angina or coronary artery disease likely to require CABG or PTCA

- Other protocol-defined exclusion criteria may apply.

Novartis Pharmaceuticals, East Hanover, New Jersey 07936, United States

Starting date: December 2005
Last updated: March 20, 2008